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Safety first, but pharmacy would support Cialis OTC switch

If erectile dysfunction medicine Cialis were to become available over the counter, would pharmacy leaders support the switch?

Man-computer-Andrey-Kryuchkov-Dreams

Source: Andrey-Kryuchkov/Dreamstime.com

Sanofi claims that having Cialis available over-the-counter would reduce the risk of men purchasing counterfeit versions online

Pharmacy leaders would not object to a switch in status for the erectile dysfunction drug Cialis (tadalafil) from prescription-only to pharmacy, but insist that user safety would have to be paramount in regulatory approval for the change.

The manufacturer of the drug, Lilly, has agreed a deal with Sanofi to allow the French firm to buy exclusive rights to apply to sell Cialis as a non-prescription medicine in Europe, the US, Canada and Australia after certain patents expire.  

Sanofi says that removing the need for users to get a doctor’s prescription would stop many consumers from sourcing the drug on the internet, from which, it claims, 60% of medicines sold are counterfeit. “When you know that 30% of the total online sales are related to erectile dysfunction, you see the issue,” Vincent Warnery, senior vice president of Sanofi’s global consumer healthcare division, told the annual meeting of the Association of the European Self-Medication Industry (AESGP) in London this month.

Despite significant investment in disease awareness campaigns, most men do not consult their doctor for erectile dysfunction, he said. “Men search online for products they can access directly and in doing so they expose themselves to the huge risk of counterfeiting.”

Luc Besançon, general secretary of the International Pharmaceutical Federation (FIP), which represents three million pharmacists worldwide, told The Pharmaceutical Journal: “We are not against the switch in principle, but the key element is to see how it is done … in terms of support to pharmacists, requirements for the pharmacists and in what way the pharmacist will be facilitated in their work to do that properly.”

Besançon raised the issue of how patient safety and outcome would be monitored and how to overcome the risk of diversion of Cialis to other patients. He said pharmacists, the industry and the regulator would need to work together to build a framework for safe use of the product. “In theory, we support this switch. If there is a proper environment to ensure the safe use of Cialis, then there is no objection from the pharmacist side.”

Ash Soni, vice-chairman of the Royal Pharmaceutical Society’s English Pharmacy Board, told The Pharmaceutical Journal that the RPS would support any switch provided the right criteria for sale are met and there is responsible advertising to promote the product to the right population. His pharmacy, in Streatham, South London, already supplies Cialis to patients via a patient group direction, a legal framework that allows medicines to be supplied without a prescription for specific patient groups. “There is a huge amount of demand out there.”

Soni says that a switch should not be complex in practice. For example, when migraine treatment Imigran Recovery (sumatriptan) became available over the counter (OTC) in the UK, patients and pharmacists did not like it because a form had to be filled out. “We must not make it impossible to buy and we should recognise the professional responsibility and accountability of pharmacists,” says Soni.

John Chave, secretary general of the Pharmaceutical Group of the European Union (PGEU), which represents pharmacists in Europe, told The Pharmaceutical Journal: “There is a good case for switching, because the fact is too many men go onto the internet to get this product, whether it is for a lifestyle reason or for a perfectly legitimate reason.”

Rigorous procedure

Sanofi’s application to switch Cialis in Europe will go through the European Medicines Agency’s centralised procedure – a stringent assessment after which few OTC switches are approved (see panel). Pfizer tried to switch its erectile dysfunction medicine Viagra (sildenafil) in 2008 but failed after a negative response from the agency. However, Guido Rasi, executive director of the EMA, told the meeting that not all applications that go through the centralised procedure are the same.

Pfizer withdrew its application after the agency’s expert committee, the Committee for Medicinal Products for Human Use, said it was concerned that removing a doctor’s supervision of access to Viagra could delay or prevent the diagnosis of underlying diseases, including coronary disease.

The committee was also concerned that Viagra could be used outside its approved indication, such as for recreational purposes by young people.

Chave says arguments promoting the role of pharmacy – where a pharmacist would provide the product but advise the patient to get their heart checked by a doctor — were unsuccessful.

The PGEU does not endorse individual switches but tries to highlight the pharmacist’s role and discusses effective training with the industry. Chave said that he personally thinks Cialis would be a “good” candidate for a switch, but “whether pharmacists will feel happy dispensing that product is something we need to talk about”.

Industry view: trust in pharmacy

The UK’s OTC industry association is also supportive of the switch but said it required solid trust in pharmacy. Asked what is the biggest barrier to switching a product like Cialis, Gopa Mitra, director of health policy and public affairs at the Proprietary Association of Great Britain, told The Pharmaceutical Journal: “It could be cultural, societal, and then it could be about the trust in pharmacy that they do a good job.”

She adds: “We need the right information for the pharmacists, the right information with the product, and the right level of information/education out there.”

A switch in approach?

Cialis is a centrally approved product, so any switch application must go through the European Medicines Agency (EMA) centralised procedure, a process which has brought only three successful switches for active substances out of seven applications made since the new scheme was introduced in 2005.  

The three successes are: GlaxoSmithKline’s anti-obesity medicine Alli (orlistat) in 2008; and two acid-reflex treatments, Takeda’s Pantoloc Control (pantoprazole) in 2009 and Pfizer’s Nexium Control (esomeprazole) in 2013.

There was one negative opinion and recommended refusal (for sumatriptan), two withdrawals (for Viagra and ibuprofen/diphenhydramine) and there is one ongoing application (EllaOne, an emergency hormonal contraceptive containing ulipristal).

John Chave, secretary general of the Pharmaceutical Group of the European Union (PGEU), thinks the centralised procedure “fails” because the EMA’s Committee for Medicinal Products for Human Use, which makes decisions, is “full of medical doctors”.

“You’ve got to deal with all the medical doctors in Spain and Italy and all these [European] countries and they tend to say we can’t trust pharmacists to do that, they haven’t got the skills. So pharmacy has come out of the whole centralised procedure rather badly and one of our missions in the PGEU is to try to change that.” Does the composition of the committee need to change then? He answers: “It would be good to have more pharmacists on it.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065364

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